Solta Medical Announces FDA 510(k) Clearance of New Fraxel re:store Dual Laser System

Solta Medical, Inc., recently announced it has received FDA 510(k) clearance for the new Fraxel re:store Dual laser system. The Fraxel re:store Dual system adds a novel 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market, to the company’s existing technology. The new Fraxel re:store Dual system is optimized for both on face and large body areas to address clearance of pigmentation and other superficial skin conditions all in a single treatment, according to Solta Medical.

Prior to the non-ablative Fraxel re:store Dual system, laser skin resurfacing procedures were largely limited to the face. The expanded versatility of the Fraxel re:store Dual system, with the addition of the new 1927 nm wavelength, increases the areas of the body that physicians can treat.

According to Solta Medical, the new Fraxel re:store Dual system provides significant enhancements that enable physicians to better address pigmentation and other dyschromia on the entire body. According to the company, the Fraxel re:store Dual system features a dual fiber laser technology in one system, an accelerated clearance of unwanted pigmentation, and ease of operation and improved patient comfort with focal cooling built directly into the hand piece. It also allows for treatment of larger and multiple body areas in a single session with the addition of the 1927 nm wavelength and increased procedure speed by 25% with newly improved scanner design.

The Fraxel re:store 1550 nm laser is FDA cleared for skin resurfacing and for the treatment of pigmented lesions, acne scars, melasma, mild to moderate periorbital rhytids, surgical scars and actinic keratosis. The Fraxel re:store 1927 nm laser is FDA cleared for dermatological procedures requiring the coagulation of soft tissue.

__________________

New Pediatric Indication for Locoid Lipocream

Triax Pharmaceuticals, LLC, recently announced the approval of new labeling for Locoid Lipocream (hydrocortisone butyrate, 0.1%), a mid-potency corticosteroid brand indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. The new labeling now includes an indication for topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age to 18 years of age.

According to Triax, a large pivotal study confirmed treatment success with Locoid Lipocream. Results of the study, which were published in Cutis in 2009, showed that more than 60% of patients were determined “clear” or “almost clear” as measured by physician’s global assessment (n=264). Also in this study by Abramovits et al, body surface area evaluation showed significant effects favoring Locoid Lipocream. The product was also measured as “superior” by pruritis scores and 43% of patients treated with Locoid Lipocream had at least a 2-point improvement in itching, compared to 21% of vehicle-treated patients. Of those patients treated with Locoid Lipocream, 80% had at least a 1-point improvement vs. 54% for vehicle.

Matheson et al showed that additional benefits of Locoid Lipocream include very low HPA axis suppression in patients 3 months of age and older (n= 84), with only 5 of 84 patients (6%) showing laboratory evidence of HPA axis suppression, in a study published in 2008 in the Journal of Drugs in Dermatology.

Adverse events in the large clinical pediatric study (n = 264) in atopic dermatitis were limited to application site reactions and acne but were not statistically different than the vehicle.

Pediatric patients in all studies were treated for up to 4 weeks with Locoid Lipocream.

Locoid Lipocream is available in a 15g, 45g or a 60g tube, and Locoid Lotion is available in a 2 fl. oz. or a 4 fl. oz. bottle.

___________________

American Academy of Dermatology Issues New Guidelines for the Management of Psoriasis With Ultraviolet Light Therapy

The American Academy of Dermatology (AAD) has released new guidelines of care for the management and treatment of psoriasis with ultraviolet (UV) light therapy. Recommendations for the use of the most common forms of UV light therapy as stand-alone treatments or in conjunction with other therapies were outlined, including patient considerations. This set of guidelines is the AAD’s fifth of six sections of the guidelines of care for psoriasis.

UVB Therapy

Used successfully to treat psoriasis for more than 75 years, the chief advantage of broadband (BB)-UVB therapy is that it can be used to treat a large area of psoriasis by exposing the affected skin to a specific wavelength of UVB light. However, narrowband (NB)-UVB therapy, which was introduced in the 1990s, has been shown to be more effective in clearing psoriasis than BB-UVB, with studies showing more rapid clearing and better remission rates.

Risks and Recommendations. While both therapies are generally well-tolerated, patients must be educated as to the potential long-term side effects of UVB — including an increased risk of skin cancer and premature aging. Because there is also an increased risk of UVB-related cataracts, patients should protect their eyes with goggles during treatment.

Other minor side effects of BB-UVB therapy include redness, itching, and stinging. Burning also is a possible side effect of NB-UVB, and David M. Pariser, MD, FAAD, president of the AAD, noted in a press release, that, although not commonly reported, there have been instances of skin blistering after exposure to NB-UVB.

Pregnant Women and Children. Neither BB-UVB nor NB-UVB therapy are known to cause birth defects or disrupt a pregnancy.

Studies examining the use of and long-term safety of UVB therapy in children are limited, but Dr. Pariser explained that this therapy could be considered as a second option in selected children whose psoriasis does not respond to topical therapy as long as the light therapy is closely monitored by a dermatologist.

Alone or in Combination. In some cases, UVB therapy is effective when used by itself to clear psoriasis, but dermatologists commonly use this therapy in combination with topical or systemic medications. Dr. Pariser emphasized that the decision to use combination therapy should be made on a case-by-case basis and should be tailored to meet individual patients’ needs.

PUVA Photochemotherapy

Psoralens are available as oral or topical medications that patients must use before being exposed to UVA light, or, less commonly, in a bath formula that patients soak in prior to UVA exposure. Two large, multicenter studies have demonstrated the efficacy of PUVA in the treatment of psoriasis, and Dr. Pariser noted that PUVA treatment often leads to the clearing of psoriasis typically within 24 treatments, with remissions lasting between 3 and 6 months.

Risks and Recommendations. “The introduction of PUVA for the treatment of psoriasis was a major advance for patients with severe psoriasis, as it offered them an outpatient therapy rather than other treatments that required hospitalization,” said Dr. Pariser. “However, studies show that high cumulative exposure to oral PUVA is associated with an increase in the risk of non-melanoma skin cancer, particularly squamous cell carcinoma, which is why dermatologists often reserve PUVA for psoriasis patients who have not responded favorably to other treatments.”

In an effort to minimize the total dosage of PUVA, dermatologists often combine PUVA treatments with other therapies (such as retinoids) or in rotation with other treatments. In addition to the increased risk of skin cancer and skin aging with long-term use, other common side effects of PUVA include redness, itching, dryness, irregular pigmentation, nausea and vomiting. PUVA also is not recommended for use in children or in patients with certain medical conditions, which is why dermatologists closely evaluate patients before PUVA is considered as a treatment option for psoriasis.

Targeted Phototherapy (Excimer Laser)

Excimer lasers selectively target affected lesions without treating unaffected skin — therefore minimizing the potential risk of exposing uninvolved skin to UV radiation. Another advantage is that because only the affected areas are treated, higher doses can be administered in fewer treatment sessions.

Risks and Recommendations. Although numerous studies have demonstrated that treatment with the excimer laser can clear psoriasis, there is limited information about the duration of remission and the recommended dosage and scheduling of therapy. Dr. Pariser explained that most patients experience long-term improvement following treatment with the excimer laser, and currently the dose of energy delivered is guided by the patients’ skin type and thickness of the psoriasis plaques.

“Typically, patients receive treatment with the excimer laser two to three times a week, with a minimum of 48 hours between treatments,” said Dr. Pariser. “Side effects are minimal and are limited to the treatment area, with redness, burning and darkening of the skin being the most common. There have been cases where blistering has occurred with the use of higher doses of energy, but for the most part treatments are well-tolerated — even in children.”

Patient Considerations for UV Light Therapy

Like all treatments for psoriasis, some patients make better candidates for UV light therapy than others. Before UV light therapy is considered, all patients must have a complete history and physical examination and be made aware of the potential long-term risks.

Contraindications. “Patients with a known history of lupus or xeroderma pigmentosum should not be treated with phototherapy,” said Dr. Pariser. “In addition, patients with atypical nevi, multiple non-melanoma skin cancers, multiple risk factors for melanoma, a history of melanoma, a history of photosensitivity disorder, or who are taking photosensitizing medications or are immunosuppressed as a result of organ transplantation should be screened carefully before starting UV light therapy.”

Dosing. Recommended dosing guidelines for both BB-UVB and NB-UVB vary by skin type, with light-skinned patients receiving much smaller initial and incremental doses of UV light than darker-skinned patients.

Conclusion

“For the right patients and with close monitoring by a dermatologist, UV light therapy can be a safe and effective treatment for psoriasis patients who might not have responded well to other traditional therapies or for various reasons might not be good candidates for systemic medications,” said Dr. Pariser. “Dermatologists can recommend the best treatment plan for patients with mild to severe psoriasis, helping them improve their condition and overall quality of life.”

____________________

In Brief…

Safeguard Scientifics, Inc., led…$17.4 million Series B financing for Quinnova Pharmaceuticals with participation from existing investors Thomas, McNerney & Partners and H.I.G. BioVentures. Quinnova will use the proceeds to fund a Phase III clinical trial for an NDA product, expand its sales and marketing capabilities, facilitate the company’s other NDA and medical device clinical trials, and fund research and development initiatives to bring new products to market.

American Academy of Dermatology has named… Samantha Sheridan Director of Science & Quality. In her new role, Sheridan will oversee the activities under the purview of the Council on Science and Research, as well as the Patient Safety and Quality Committee, including guidelines and performance measure development, informatics, survey research and data collection.

SkinMedica and New York University entered… into a license agreement for a hyperpigmentation program. Under the terms of the agreement, SkinMedica has licensed exclusive rights to develop and market products based on the NYU technology, with a range of applications in the modulation of skin pigmentation.

Clarisonic has been named… to the Inc. 500 List of fastest growing private companies in America.

Foamix Ltd, has extended… its agreement with Galderma to develop an innovative medicated foam for an additional dermatological indication.

_________________

AAD Launches New Web Site to Teach Kids about Healthy Skin, Hair and Nail Habits

The American Academy of Dermatology announced its launch of a new interactive Web site created by dermatologists that teaches children how to practice good skin care virtually, or risk the consequences of pimples, greasy hair, a poison ivy rash and sunburn. The Web site, www.KidsSkinHealth.org, provides information about caring for skin, hair and nails to kids ages 8 through 12 and their parents.

The Web site features two portals — For Kids and For Grown Ups. The Kids Portal features Sammy the Skin Cell to guide kids through the site. The site offers information on conditions that can affect children as well as fun facts, answers to common questions and a dictionary that includes audio pronunciations. The site allows kids to play “It’s a Skin Cell’s Life,” a game that lets them earn points by using their new-found knowledge for various tasks.

The Grown Ups Portal guides parents in helping their children care for their skin, hair and nails, and provides information about adult conditions, such as rosacea and psoriasis, and how to care for aging skin. The site also includes activities for parents to do with their children and answers to common questions.

To develop the Web site, the Academy surveyed kids and moms about what they’d like to see on a Web site about skin, hair and nails.

The Web site’s content was developed by the AAD. Industry support, which helped underwrite the cost of the Web site’s creation, was provided by Beiersdorf, Inc., Dermik Laboratories, Galderma Laboratories, L.P., Graceway Pharmaceuticals, LLC, Intendis, Inc., Merz Pharmaceuticals, LLC, Ortho Dermatologics, PharmaDerm, Procter & Gamble, and Stiefel Laboratories, Inc.

_________________

STUDY ASSESSES SKIN HYDRATION AND EPIDERMAL FUNCTION OF 2.5% AND 5% BENZOYL PEROXIDE-CLINDAMYCIN COMBINATIONS

A poster describing a new study of an optimized once-daily fixed combination of clindamycin phosphate 1.2% and BPO 2.5% (clin-BPO 2.5%) showed that the clin-BPO 2.5% formulation maintains skin hydration and does not damage the skin barrier.

The objective of this study, presented at the Fall Clinical Dermatology Conference and disseminated as a press release by Acanya manufacturer, Valeant Pharmaceuticals, was to compare the effects of clin-BPO 2.5% (Acanya Gel) and clin-BPO 5% (BenzaClin Topical Gel) on epidermal functions and irritation.

Study. The single-center, randomized, controlled observer-blind study enrolled 22 subjects (4 male and 18 female, ages 21 to 77, mean 45.6 years) with healthy volar forearm skin. Test fields on the volar forearms were treated non-occlusively with 50 μl (50 mg) of once-daily clin-BPO 2.5% and twice-daily clin-BPO 5% according to the dosage and administration sections of each product’s respective package insert and applied by study site personnel. All subjects received the same treatments during an 11-day treatment period. An additional untreated test field served as a control. Measurements assessing the skin barrier and skin hydration were performed.

Findings. The study demonstrated that once-daily clin-BPO 2.5% was superior in maintaining skin hydration to twice daily clin-BPO 5%. A statistically significant decrease in skin hydration was seen with clin-BPO 5%, reflecting a drying effect. Clin-BPO 2.5% revealed no relevant irritant effect or significant negative influence on skin hydration and no evidence of epidermal barrier impairment.

Previous Efficacy and Tolerability Findings. In clinical studies in more than 2,800 acne patients, the once-daily fixed combination of clindamycin phosphate 1.2% and BPO 2.5% (clin-BPO 2.5%) was shown effective in reducing inflammatory and noninflammatory lesions in patients with moderate to severe acne with minimal local cutaneous side effects.

_________________

Drug Could Provide First Treatment For Scleroderma

G leevec, a drug that is currently approved to treat certain types of cancer, could provide the first treatment for scleroderma, according to data presented at the annual meeting of the American College of Rheumatology and a press release from the Hospital for Special Surgery (HSS) in New York.

Study. The study was the largest single center trial of Gleevec in scleroderma to date with the longest duration of treatment and follow-up. In it, researchers at HSS, led by Robert Spiera, MD, an associate attending rheumatologist, enrolled 30 patients with diffuse scleroderma; they were given 400 mg of Gleevec per day and reviewed monthly for 12 months. They were seen for follow-up 3 months after discontinuing the drug.

To measure the effectiveness of the drug, researchers used a modified Rodnan skin score, a measure of how much skin is affected by the disease. The investigators also measured lung function using tests for forced vital capacity (FVC) as well as diffusion capacity.

Interim Results. The investigators reported an interim analysis of their results, although the study is ongoing. At 1 year, they saw a 23% improvement in skin scores and an improvement in FVC by 9.6% and diffusion capacity scores by 11% in the 18 patients who had completed 1 year of treatment.

Conclusion. Before this trial, test tube studies of human cells indicated that Gleevec might have some activity in combating the disease, and the drug was shown to be effective in a rodent model of the disease. Only anecdotal evidence, however, had been published on the drug’s effectiveness in treating the disease in humans. Dr. Spiera said the findings of his open-label study need to be interpreted cautiously, and ultimately corroborated by evidence from a randomized controlled trial, the gold standard of clinical trials.